Approval Probability
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ML Risk
Also known as DAPTACEL®: DTaP
DAPTACEL: DTaP · 1 trial · 3 indications
Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.
Booster response calculation: If pre-Dose 5 titer \< 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.
| Arm | Type | Description |
|---|---|---|
| DAPTACEL Primed | EXPERIMENTAL | Participants received Daptacel in Study P3T06. |
| Pentacel Primed | EXPERIMENTAL | Participants received Pentacel in Study P3T06 |
| Name | Type | Description |
|---|---|---|
| DAPTACEL®: DTaP | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged ≥ 4 and \< 7 years from date of birth at the time of study vaccination * Signed and dated Investigational Review Board (IRB)-approved informed consent from a parent or legally authorized representative. Signed and dated IRB-approved assent from subject if required by IRB ...
DAPTACEL is a DTaP vaccine used to protect against diphtheria, tetanus, and pertussis. It is given as a five-dose series in children, including a fifth dose for children 4 to 6 years old who previously received four doses of Pentacel or DAPTACEL. It is developed by Sanofi.
DAPTACEL is made by Sanofi, which trades under the ticker SNY. Sanofi develops and manufactures the DTaP vaccine for protection against diphtheria, tetanus, and pertussis in children.
DAPTACEL has been studied in Phase 3 clinical development. A completed Phase 3 trial evaluated its safety and immunogenicity as a fifth dose in children 4 to 6 years old after four prior doses of Pentacel or DAPTACEL.
DAPTACEL has been evaluated in the completed Phase 3 trial NCT00258895, titled Safety and Immunogenicity of DAPTACEL as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel or DAPTACEL. The trial enrolled 649 healthy children aged 4 years and older in the United States.
DAPTACEL is a DTaP vaccine, meaning it combines diphtheria, tetanus, and pertussis antigens in a single product. DTaP is the general category name for this type of combination vaccine, and DAPTACEL is Sanofi's branded DTaP product.
The DAPTACEL Phase 3 trial NCT00258895 enrolled 649 participants. It was a controlled study in healthy children aged 4 years and older in the United States, evaluating a fifth dose after four prior doses of Pentacel or DAPTACEL.